Unregulated implants

I’m talking here about devices such as artificial joints, pacemakers, stents, surgical mesh, vein filters, insulin pumps and the like. In 2015 the FDA received around sixteen thousand reports of deaths associated with such medical devices. But the number is surely higher: 99 percent of “adverse events” are not reported. The more serious the event, the less likely it is to be reported. The true number of those deaths could be as high as 1.6 million, making them one of the leading causes of death in the US. About 1,100 of these devices are recalled annually. In 2013, 33,000 inferior vena cava filters were recalled. Instead of stopping blood clots from reaching the heart, the filters actually caused clots to form.

Regulation of these devices is lax. Depending on the level of risk, manufacturers can simply register them with the FDA prior to putting them on the market or provide “reasonable assurance” of their safety and efficacy. Clinical testing is the exception rather than the rule. Since 1976, the FDA had approved more than a thousand high-risk devices, such as pacemakers. Of those, only sixteen percent had gone through rigorous clinical testing before sale. Of the four hundred moderate-to high-risk implants approved for market between 2008 and 2012, no clinical testing was required. These devices included stents, replacement hips, surgical mesh, and similar implants.

Of course, device makers make huge profits from their products. In 2014, the industry’s estimated revenue was more than $136 billion. To increase sales, they strive to constantly innovate. Thus, more untested devices come onto the market.

Unlike Canada, Australia, Japan, New Zealand and several European countries, the US has no registry of implants that would provide the FDA, doctors, and patients with the risks and benefits of implants over time. Repeated efforts to implement a registry system in the US have failed, thanks to the implant industries’ powerful lobby.

   

As it is, people with implants are participants in a large uncontrolled experiment.

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